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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device folders and injectors, intraocular lens (iol)
Product CodeMSS
Regulation Number 886.4300
Device Class 1


Premarket Reviews
ManufacturerDecision
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AST PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BAUSCH & LOMB, INC
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON SURGICAL VISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
RXSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 2
STAAR SURGICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 114 114
2018 340 340
2019 271 271
2020 362 362
2021 289 289
2022 405 405

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 344 344
Crack 250 250
Adverse Event Without Identified Device or Use Problem 248 248
Device Damaged by Another Device 167 167
Scratched Material 155 155
Material Split, Cut or Torn 140 140
Break 134 134
Contamination /Decontamination Problem 76 76
Split 60 60
Physical Resistance/Sticking 39 39
Contamination 34 34
Defective Device 26 26
Burst Container or Vessel 22 22
Material Fragmentation 22 22
Use of Device Problem 17 17
Insufficient Information 17 17
Fracture 15 15
Device Operates Differently Than Expected 14 14
No Apparent Adverse Event 14 14
Appropriate Term/Code Not Available 13 13
Material Deformation 13 13
Mechanical Problem 11 11
Difficult to Remove 11 11
Particulates 11 11
Material Separation 10 10
Fitting Problem 10 10
Sticking 9 9
Material Twisted/Bent 9 9
Activation, Positioning or Separation Problem 9 9
Failure to Advance 9 9
Mechanical Jam 8 8
Device Handling Problem 8 8
Torn Material 8 8
Failure to Eject 8 8
Difficult to Advance 7 7
Defective Component 7 7
Difficult to Insert 6 6
Inaccurate Delivery 5 5
Material Integrity Problem 5 5
Detachment of Device or Device Component 4 4
Entrapment of Device 4 4
Material Rupture 4 4
Unintended Ejection 3 3
Detachment Of Device Component 3 3
Malposition of Device 3 3
Deformation Due to Compressive Stress 3 3
Positioning Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Noise, Audible 2 2
Ejection Problem 2 2
Folded 2 2
Patient-Device Incompatibility 2 2
Dent in Material 2 2
Physical Resistance 2 2
Device Markings/Labelling Problem 2 2
Device Dislodged or Dislocated 2 2
Material Protrusion/Extrusion 2 2
Bent 2 2
Loose or Intermittent Connection 2 2
Improper or Incorrect Procedure or Method 2 2
Inadequacy of Device Shape and/or Size 2 2
Product Quality Problem 2 2
Melted 1 1
Material Opacification 1 1
Device Slipped 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Device Damaged Prior to Use 1 1
Stretched 1 1
Unstable 1 1
Vibration 1 1
Difficult to Fold, Unfold or Collapse 1 1
Peeled/Delaminated 1 1
Difficult To Position 1 1
Off-Label Use 1 1
Material Puncture/Hole 1 1
Biofilm coating in Device 1 1
Complete Blockage 1 1
Difficult or Delayed Positioning 1 1
Inappropriate or Unexpected Reset 1 1
Device Contaminated During Manufacture or Shipping 1 1
No Pressure 1 1
Physical Property Issue 1 1
Device Operational Issue 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Expiration Date Error 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Failure to Deliver 1 1
Device Displays Incorrect Message 1 1
Wrinkled 1 1
Contamination of Device Ingredient or Reagent 1 1
Delamination 1 1
Delivery System Failure 1 1
Activation Problem 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Pressure Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 569 569
No Clinical Signs, Symptoms or Conditions 462 462
Insufficient Information 283 283
No Consequences Or Impact To Patient 162 162
Capsular Bag Tear 77 77
No Code Available 77 77
Vitrectomy 50 50
Foreign Body In Patient 33 33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
No Information 21 21
Eye Injury 21 21
Visual Impairment 15 15
No Patient Involvement 13 13
Vitreous Loss 10 10
Inflammation 10 10
Failure of Implant 10 10
Corneal Edema 10 10
Visual Disturbances 8 8
Device Embedded In Tissue or Plaque 7 7
Endophthalmitis 6 6
Foreign Body Sensation in Eye 6 6
Pain 5 5
Blurred Vision 4 4
Hemorrhage/Bleeding 3 3
Edema 3 3
Corneal Abrasion 3 3
Unspecified Eye / Vision Problem 3 3
Eye Pain 2 2
Toxic Anterior Segment Syndrome (TASS) 2 2
Hyphema 2 2
Hypopyon 2 2
Uveitis 2 2
Loss of Vision 2 2
Halo 2 2
Injury 1 1
Reaction 1 1
Rupture 1 1
Increased Sensitivity 1 1
Tissue Damage 1 1
Iritis 1 1
Unspecified Infection 1 1
High Blood Pressure/ Hypertension 1 1
Vitreous Floaters 1 1
Corneal Decompensation 1 1
Failure to Anastomose 1 1
Abrasion 1 1
Conjunctivitis 1 1
Corneal Perforation 1 1
Corneal Touch 1 1
Patient Problem/Medical Problem 1 1
Zonular Dehiscence 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aaren Scientific Inc. II Nov-08-2017
2 Alcon Research, Ltd. II Jan-09-2017
3 Bausch & Lomb Surgical, Inc. II May-16-2017
4 Rayner Intraocular Lenses Limited II Apr-21-2020
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